NDAORALTABLETPriority Review
Approved
Aug 1951
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
3/8 — Basic
Priority Review
ANTABUSE (disulfiram) by Teva is clinical pharmacology: disulfiram produces a sensitivity to alcohol which results in a highly unpleasant reaction when the patient under treatment ingests even small amounts of alcohol. First approved in 1951.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ANTABUSE (disulfiram) is an oral small molecule approved in 1951 for alcohol use disorder that works by blocking acetaldehyde metabolism, causing severe flushing, nausea, and cardiovascular symptoms if alcohol is consumed. The drug produces a conditioned aversion response by allowing toxic acetaldehyde to accumulate 5-10 times higher than normal, creating a powerful behavioral deterrent. Sensitivity increases with prolonged use and persists for 1-2 weeks after the last dose.
LOE Approaching
As a mature, generic-vulnerable asset with low competitive pressure (30%), the brand team is likely small and focused on niche positioning rather than expansion.
Mechanism of Action
CLINICAL PHARMACOLOGY: Disulfiram produces a sensitivity to alcohol which results in a highly unpleasant reaction when the patient under treatment ingests even small amounts of alcohol. Disulfiram blocks the oxidation of alcohol at the acetaldehyde stage. During alcohol metabolism following…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
Treatment of Advance Gastric Cancer With Disulfiram
Started Jun 2023
40 enrolled
Chemotherapy；Advanced Gastric Cancer；Cisplatin；Disulfiram
Study of Disulfiram and Copper Gluconate in Patients With Treatment-Refractory Multiple Myeloma
Started May 2021
2 enrolled
Multiple Myeloma
Disulfiram-Copper Gluconate in Met Pancreas Cancer w Rising CA19-9 on Abraxane-Gemzar, FOLFIRINOX or Gemcitabine
Started Oct 2019
1 enrolled
Metastatic Pancreatic Cancer
Combination Latency Reversal With High Dose Disulfiram Plus Vorinostat in HIV-infected Individuals on ART
Started Aug 2017
5 enrolled
HIV Infections
A Phase Ib Study of Intravenous Copper Loading With Oral Disulfiram in Metastatic, Castration Resistant Prostate Cancer
Started Jul 2017
9 enrolled
Prostate Cancer
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.